A Study Evaluating the Immunotherapy Treatment for Ovarian Cancer and Other Advanced Malignancies.

NCT07389239 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-02-20

No results posted yet for this study

Summary

This phase I/IIA trial studies the side effects and best dose of gene-modified T cells when given with or without decitabine, and to see how well they work in treating patients with malignancies expressing cancer-testis antigens.

Conditions

Interventions

DRUG

Decitabine

Decitabine taken by mouth 15 mg/m2/day x 5 days, IV; Days -10 to -6

DRUG

Cyclophosphamide Conditioning

Cyclophosphamide Conditioning will be 45 mg/kg x 2 days IV; Days -4 \& -3

BIOLOGICAL

NY-ESO-1 TCR/ dnTGFβRII

The dose of NY-ESO-1 TCR/ dnTGFβRII to be tested will vary depending on assigned arm.

DRUG

Aldesleukin

Aldesleukin taken by mouth500,000 IU/m2 SC BID; Days +1 to +10

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Daniel Olson · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-23
Primary Completion
2031-12-10
Completion
2031-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07389239 on ClinicalTrials.gov